WATCHMAN Elite Device for Stroke Prevention in AF

Elite AF IDE Trial (Elite AF)

Recruiting N/A Interventional Study
Atrial Fibrillation (AF) Stroke
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
400 (estimated)
Sponsor
Boston Scientific Corporation · Industry
Who this trial is looking for

This trial is looking for adults with non-valvular atrial fibrillation who want a non-drug option to prevent strokes. Participants will receive a device designed to close a part of the heart that can cause blood clots.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with non-valvular atrial fibrillation.
  • I want an alternative to anticoagulation therapy.
  • I have a CHA2DS2-VASc score of 2 or higher if male, or 3 or higher if female.
  • I can provide written consent to join the trial.
  • I can attend follow-up visits after the procedure.

You may not be able to join if

  • I am pregnant or planning to become pregnant during the trial.
  • I have a life expectancy of less than 2 years.
  • I have serious heart or kidney problems.
  • I had a heart procedure or surgery within the last 30 days.
  • I have a significant active bleeding issue.
  • I have had a stroke or TIA in the last 90 days.
  • I have a known heart tumor.
  • I have a documented history of complex atheroma.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. The subject is of legal age to participate in the study per the laws of their respective geography. 2. The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve). 3.…
Contacts

Patricia Keating

1-800-CARDIAC

patricia.keating@bsci.com

CONTACT